| Publication CODE |
Title |
| CEN/TR 17223:2018 (2018-03) |
GUIDANCE ON THE RELATIONSHIP BETWEEN EN ISO 13485: 2016 (MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES) AND EUROPEAN MEDICAL DEVICES REGULATION AND in VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
98.00 €
|
85. |
Description
This Technical Report provides guidance on the relationship between the requirements in the European Regulations for Medical Device and In Vitro Diagnostic Medical Devices and EN ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.
|
| Class |
C
|
| Status |
TECHNICAL REPORT |
| Situation |
Currently active
|
|
| Committee |
CEN/CLC JTC 3
QUALITY MANAGEMENT AND CORRESPONDING GENERAL ASPECTS FOR MEDICAL DEVICES
|
| BEC Approval |
2018-02-12 |
| ICS-Code (International Standards Classification) |
03.100.70
, 11.040.01
|
| NBN Status |
New |
|
| Date of ratification (d.o.r.) |
2018-02-12 |
| Date of availability (d.a.v.) |
2018-03-21 |
|
